Clinical Trial: Tocilizumab Effect iN pOlymyalgia Rheumatica
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Open 24 Weeks Study to Evaluate Effect and Safety of Tocilizumab as the First Line Therapy in Subjects With Polymyalgia Rheumatica (PMR)
Brief Summary:
Phase 1:
Patients are treated with infusions of Tocilizumab (TCZ) for 3 months. Clinical evaluation is performed using PMR-AS.
The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST) [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).
At the end of the phase 1,the patients stop TCZ and entered in phase 2 at week 12.
Phase 2:
All the patients are included in the phase 2 and treated with glucocorticoid (GC)for 3 months. Two arms are possible according to the PMR-AS. Either the classical GC treatment (0.3mg/kg), either a low dose group of GC(0.15mg/kg) .
Detailed Summary:
Sponsor: University Hospital, Brest
Current Primary Outcome: Efficacy at W12 [ Time Frame: 12 Weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Safety and efficacy during the study [ Time Frame: Week 2,4,8,12,16,20 and 24 ]
- To maintain low disease activity (PMR-AS) in the low corticosteroid dose group from W12 to W24
- On the inflammatory changes (synovitis, myositis, tenosynovitis aund bursitis) between baseline, W2 and 12 visualize by ultrasonography, MRI and Tep-Scan.
- On sparing corticosteroid, with the comparison of the cumulative corticosteroid dosage beetwen the two groups of patients in the phase 2, W12 to 24.
- On the circulating serum cytokines and immunoregulators (IL-6, IL-1, BLyS/BAFF, IL-6 receptor, gp130) and B cells receptors and on the phenotype of circulating T- and B-cells between baseline and W4 and 12 On inflammatory parameters (CRP and ESR) between baseline and W 2,4,8,12,16,20 and 24
- On the quality of life of patients between baseline and W 4,12,16, 20 and 24
- To evaluate the side-effects in relation to the use of Tocilizumab treatment. [ Time Frame: After first, second and third treatment and during follow up ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Brest
Dates:
Date Received: September 17, 2012
Date Started: July 2012
Date Completion:
Last Updated: February 10, 2015
Last Verified: January 2015